SOMA- carisoprodol tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

CARISOPRODOL (UNII: 21925K482H) (CARISOPRODOL - UNII:21925K482H)

Tilgjengelig fra:

STAT RX USA LLC

INN (International Name):

CARISOPRODOL

Sammensetning:

CARISOPRODOL 250 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

SOMA is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. SOMA should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [see Dosage and Administration (2) ]. SOMA is contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate. There are no data on the use of SOMA during human pregnancy. Animal studies indicate that carisoprodol crosses the placenta and results in adverse effects on fetal growth and postnatal survival. The primary metabolite of carisoprodol, meprobamate, is an approved anxiolytic. Retrospective, post-marketing studies do not show a consistent association between maternal use of meprobamate and an increased risk for particular congenital malformations. Teratogenic effects:

Produkt oppsummering:

250mg Tablets: round, convex, white tablets, inscribed with SOMA 250; available in bottles of 100 (NDC 0037-2250-10) and bottles of 30 (NDC 0037-2250-30). 350mg Tablets: round, convex, white tablets, inscribed with SOMA 350; available in bottles of 100 (NDC 0037-2001-01). Storage: Store at controlled room temperature 20° - 25°C (68° - 77°F).

Autorisasjon status:

New Drug Application

Preparatomtale

SOMA - CARISOPRODOL TABLET
STAT RX USA LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SOMA
SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR SOMA.
SOMA (CARISOPRODOL) TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 1959
RECENT MAJOR CHANGES
Warnings and Precautions, Sedation (5.1) 10/2009
Warnings and Precautions, Drug Dependence, Withdrawal, and Abuse (5.2)
10/2009
INDICATIONS AND USAGE
SOMA is indicated for the relief of discomfort associated with acute,
painful musculoskeletal conditions. (1)
Important Limitations:
Should only be used for acute treatment periods up to two or three
weeks (1)
Not recommended in pediatric patients less than 16 years of age (8.4)
DOSAGE AND ADMINISTRATION
Recommended dose is 250 mg to 350 mg three times a day and at bedtime.
(2)
DOSAGE FORMS AND STRENGTHS
Tablets: 250 mg, 350 mg (3)
CONTRAINDICATIONS
Acute intermittent porphyria (4)
Hypersensitivity reactions to a carbamate such as meprobamate (4)
WARNINGS AND PRECAUTIONS
Due to sedative properties, may impair ability to perform hazardous
tasks such as driving or operating machinery (5.1)
Additive sedative effects when used with other CNS depressants
including alcohol (5.1)
Cases of Drug Dependence, Withdrawal, and Abuse (5.2)
Seizures (5.3)
ADVERSE REACTIONS
Most common adverse reactions (incidence > 2%) are drowsiness,
dizziness, and headache (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MEDA PHARMACEUTICALS
INC. AT 1-800-526-3840 OR FDA
AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_.
DRUG INTERACTIONS
CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic
antidepressants) - additive sedative effects ( 5.1 and
7.1)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 11/2009
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Sedation
5.2 Drug Dependence, Withdrawal, and Abuse
5.2 Drug Dependence, Withdrawal, and Abus